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- Ensayo clínico NCT01302899
To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy (ARIA)
A Single-blind, Double Dummy, Randomized, Multi-dose, Two Sequence, Crossover, Study to Investigate the Effects of Renin Inhibitor (Aliskiren 300 mg) on Albuminuria in Non-diabetic Nephropathy Patients Treated With Ramipril 10 mg and Volume Intervention (ARIA)
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Groningen, Países Bajos
- Novartis Investigative Site
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Leeuwarden, Países Bajos
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male and female subjects, age 18 years and above
- Patients with chronic kidney disease of non-diabetic origin
- Glomerular filtration rate >30 ml/min/1.73m2
- Patients with a history of hypertension and msSBP (mean systolic blood pressure) of <160 mm Hg and msDBP (mean diastolic blood pressure) <105 mm Hg at screening and baseline.
- Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2
Exclusion Criteria:
- Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
- Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
- Pregnant or nursing (lactating) women,
- A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
- Diabetes mellitus, Heart failure
- High rate of renal function loss
- History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
- History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Other protocol-defined inclusion/exclusion criteria applied
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
Aliskiren 150 mg (Tablet)
Aliskiren 150 mg Matching Placebo (Tablet)
HCTZ 25mg (Capsule)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril 10mg (Tablet)
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Experimental: Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
Aliskiren 150 mg (Tablet)
Aliskiren 150 mg Matching Placebo (Tablet)
HCTZ 25mg (Capsule)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril 10mg (Tablet)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
Periodo de tiempo: 26 weeks
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Two 24-hour collections of urine were to be made at each study visit.
The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
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26 weeks
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Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
Periodo de tiempo: 26 weeks
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Two 24-hour collections of urine were to be made at each study visit.
The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
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26 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Sitting Systolic Blood Pressure (msSBP)
Periodo de tiempo: 26 weeks
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At study entry, blood pressure (BP) was measured in both arms.
If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used.
If there was no clinically significant difference between arms, the non-dominant arm was used through out study.
Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes.
For each sitting assessment, blood pressure was assessed at least 3 times.
From these assessments, msSBP was calculated.
All BP measurements were to be performed on the same arm.
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26 weeks
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Mean Sitting Diastolic Blood Pressure (msDBP)
Periodo de tiempo: 26 weeks
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At study entry, blood pressure (BP) was measured in both arms.
If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used.
If there was no clinically significant difference between arms, the non-dominant arm was used through out study.
Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes.
For each sitting assessment, blood pressure was assessed at least 3 times.
From these assessments, msDBP was calculated.
All BP measurements were to be performed on the same arm.
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26 weeks
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Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function
Periodo de tiempo: 26 weeks
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All patients had to visit the main center for renal function measurements.
The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran.
GFR was calculated as the urinary clearance of IOT.
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26 weeks
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Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments
Periodo de tiempo: 26 weeks
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26 weeks
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Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
Periodo de tiempo: 26 weeks
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26 weeks
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Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
Periodo de tiempo: 26 weeks
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26 weeks
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Plasma Rennin Activity (PRA)
Periodo de tiempo: Baseline to week 26
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Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26.
Plasma PRA is a direct measure of the formation of Ang I in the plasma.
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Baseline to week 26
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Plasma Rennin Concentration (PRC)
Periodo de tiempo: Baseline to week 26
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Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26.
PRC measures the concentration of immunoactive renin in the plasma.
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Baseline to week 26
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Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril
Periodo de tiempo: 26 weeks
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26 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urológicas
- Manifestaciones Urológicas
- Trastornos de la micción
- Proteinuria
- Enfermedades Renales
- Albuminuria
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antihipertensivos
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Agentes natriuréticos
- Moduladores de transporte de membrana
- Diuréticos
- Inhibidores de la enzima convertidora de angiotensina
- Inhibidores del simportador de cloruro de sodio
- Hidroclorotiazida
- Ramipril
Otros números de identificación del estudio
- CSPP100A2260
- 2009-012196-10 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Non-diabetic Nephropathy
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Ensayos clínicos sobre Aliskiren
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Chulalongkorn UniversityDesconocidoInsuficiencia de la membrana peritonealTailandia
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NovartisTerminado
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NovartisTerminadoHipertensiónBrasil, Canadá, Ecuador, Alemania, Hungría, Corea, república de, Malasia, México, Panamá, Filipinas, Singapur, Eslovaquia, España, Pavo, Reino Unido, Venezuela
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NovartisTerminadoHipertensiónEstados Unidos, Argentina, Colombia, Francia, Alemania, India, España
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NovartisTerminadoEficacia y seguridad de Aliskiren en pacientes con hipertensión leve a moderada durante el ejercicioHipertensiónSingapur, Hungría, República Checa, Reino Unido
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Novartis PharmaceuticalsTerminadoInsuficiencia cardiacaFederación Rusa, Alemania, Polonia